NCT07252024

Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care

Nurse-Led Bispectral Index (BIS)-Guided Sedation Protocol and Its Impact on Clinical Outcomes in Mechanically Ventilated Pediatric Intensive Care Patients: A Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Dr. Behcet Uz Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

Pediatric intensive care sedation is traditionally based on subjective clinical scales. Bispectral Index (BIS) monitoring provides an objective EEG-based assessment of sedation depth. This prospective, two-center randomized controlled trial evaluates whether a nurse-led BIS-guided sedation protocol can reduce excessive or inadequate sedation, sedative medication exposure, withdrawal symptoms, and PICU length of stay in mechanically ventilated children.

Detailed description

This prospective, randomized (1:1) controlled trial was conducted in two tertiary PICUs in Turkey, including mechanically ventilated children aged 1 month to 18 years requiring continuous sedation. Patients were randomly assigned to: Intervention Group: Nurse-led sedation titration using BIS values (target: light sedation 60-80, deep sedation 45-60) combined with SBS scores under physician supervision. Nurses received structured theoretical and practical training before trial initiation. Control Group: Standard sedation protocol based solely on clinical sedation assessment without BIS-guided titration (BIS monitoring available but not used for titration). Primary Outcome: Percentage and duration of time spent outside the target BIS range Total sedative medication dose (mg/kg/day equivalents) Secondary Outcomes: PICU length of stay Mechanical ventilation duration Withdrawal symptoms (WAT-1 score) Results showed significantly reduced BIS out-of-target time, lower sedative drug exposure (midazolam, ketamine, dexmedetomidine), reduced withdrawal scores, and shorter PICU stay in the intervention group.

Conditions

• Nurse's Role
• Bispectral Index
• Pediatric Sedation

Interventions

Type	Name	Description
BEHAVIORAL	BIS-Guided Sedation Protocol	A structured sedation management protocol guided by Bispectral Index (BIS) monitoring and implemented by trained PICU nurses. The protocol includes BIS target ranges (light sedation 60-80; deep sedation 45-60), artifact recognition, standardized electrode placement, and stepwise titration of midazolam, ketamine, dexmedetomidine, or fentanyl according to predefined algorithms under physician supervision.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: Turkey (Türkiye)